US regulators approve first drug shown to slow Alzheimer’s progression

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The US Food and Drug Administration has approved the first Alzheimer’s drug to slow the progression of the neurodegenerative disease, paving the way for millions of American patients to access the treatment.

The regulator said on Thursday it would give full approval to lecanumab, now known under the brand name Lekembi, which was developed by Japanese drugmaker Isai and US biotech Biogen.

Teresa Buracchio, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said a confirmatory study showed that Lekembi was a “safe and effective treatment” for Alzheimer’s patients.

“Today’s action is the first validation that a drug targeting the underlying disease process of Alzheimer’s disease has shown clinical benefit in this devastating disease,” he added.

Biogen Chief Executive Chris Wiehbacher said the approval is a “breakthrough” in the treatment of Alzheimer’s. “We are proud to be at the forefront of ushering in a new era of progress for a disease that was previously thought to be incurable,” he added.

According to the Alzheimer’s Association, more than 6.5 million Americans suffer from Alzheimer’s, which along with other dementias will cost the US approximately $345 billion in 2023.

This drug is the first to tackle the progression of the disease rather than treating the symptoms of the disease. But some researchers are concerned that the effect on the rate of cognitive decline is not “clinically meaningful.”

Last month, the FDA’s panel of experts voted unanimously that Lekembi shows “clinical benefit.”

It comes decades after many big drug companies lost hope and cut investments in Alzheimer’s research. Lecanmab was discovered by Swedish start-up BioArctic, which then partnered with larger companies.

The FDA granted accelerated approval to the drug in January based on late-stage trial results that showed it slowed the rate of cognitive decline in early Alzheimer’s patients by 27 percent.

Some patients in the trial experienced swelling and bleeding in the brain. Three of the 1,795 participants died of brain hemorrhage, including two who were taking blood-thinning drugs. Isai said the drug cannot be directly linked to the deaths.

Now that the drug is fully approved, Medicare, the US government-backed insurance for seniors, will pay for it for early-stage Alzheimer’s patients as long as their doctors have proof of how the drug works in practice. To collect participate in the database. The US list price for the drug will be $26,500 per year, although health insurers will negotiate to lower it.

The decision by the Centers for Medicare and Medicaid Services to provide coverage for the treatment is critical to enabling widespread implementation of the treatment.

Its decision against comprehensively covering Biogen and Eisai’s Alzheimer’s drug EduHelm — which won conditional approval two years ago — contributed to Biogen scrapping the commercial rollout. Trials of EduHelm did not show as significant a benefit for patients as Lekembi, and the data was controversial after one study failed.

Patients in the European Union will have to wait until early next year when the regulator will give its verdict on the drug. In the UK, Eisai submitted the drug for approval in May.